A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work
NCT ID: NCT06290128
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2024-07-12
2028-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Riliprubart Arm
Riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Riliprubart
Pharmaceutical form: Solution Route of administration: IV Infusion
Placebo
Pharmaceutical form: Solution Route of administration: IV Infusion
Riliprubart
Pharmaceutical form: Solution Route of administration: SC Injection
Placebo
Pharmaceutical form: Solution Route of administration: SC Injection
Placebo Arm
Placebo for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Riliprubart
Pharmaceutical form: Solution Route of administration: IV Infusion
Placebo
Pharmaceutical form: Solution Route of administration: IV Infusion
Riliprubart
Pharmaceutical form: Solution Route of administration: SC Injection
Placebo
Pharmaceutical form: Solution Route of administration: SC Injection
Interventions
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Riliprubart
Pharmaceutical form: Solution Route of administration: IV Infusion
Placebo
Pharmaceutical form: Solution Route of administration: IV Infusion
Riliprubart
Pharmaceutical form: Solution Route of administration: SC Injection
Placebo
Pharmaceutical form: Solution Route of administration: SC Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
-Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/ Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).
* Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP (including motor predominant), multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee.
* Participant must be refractory to either immunoglobulin therapy or corticosteroid therapy, as defined below.
* Immunoglobulinrefractory subgroup: Historic evidence of failure or inadequate response to immunoglobulin therapy prior to screening, defined as no clinically meaningful improvement or persistent INCAT score ≥2 after a minimum of:
* One dose of IVIg of 2 g/kg, followed by a second dose of 2 g/kg or two doses of 1 g/kg, with a separation of approximately 3 weeks between doses (each dose can be divided over 2 to 5 days), as indicated in the EAN/PNS 2021 guidelines OR
* SCIg maintenance therapy with at least 0.2 g/kg weekly for 5 weeks
* Corticosteroidrefractory subgroup:
Historic evidence of failure or inadequate response to corticosteroid therapy prior to screening, defined as no clinically meaningful improvement or persistent INCAT score ≥2 after a minimum of 12 weeks of corticosteroid therapy. Corticosteroid regimen can be daily oral prednisone/prednisolone, at least 60 mg, equivalent to methylprednisolone 48 mg, tapered over 6 to 8 months, or alternative regimens, e.g. pulsed high-dose corticosteroid treatment (40 mg/day oral dexamethasone or 500 mg/day IV methylprednisolone, each daily for 4 days per month for 6 months), as indicated in the EAN/PNS 2021 guidelines A clinically meaningful improvement is defined as one or more of the following:
* A ≥1 point decrease in adjusted INCAT disability score
* An increase in IRODS centile score ≥4 points
* An increase in MRC Sum score ≥3 points
* An improvement in hand grip strength of ≥8 kilopascals or
* Equivalent improvement based on information from medical records and per the Investigator's judgment
* Participant has an adjusted INCAT score of 2 to 9
--(a score of 2 should be exclusively from the leg disability component of INCAT).
* Any allowed immunosuppressant drugs (azathioprine, cyclosporine, or mycophenolate mofetil) have been taken for ≥6 months at a stable dose for ≥3 months prior to Screening
* Participant may be receiving low-dose oral corticosteroids (≤20 mg/day of prednisone \[or equivalent dose for other oral corticosteroids\]), but only if taken at a stable dose for ≥3 months prior to Screening
* Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥ 2 points at Screening
* Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention
* All participants must agree to use contraception methods during and after the study as required.
* Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 55 weeks after the last dose of study medication:
* Refrain from donating or cryopreserving sperm PLUS
* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
* Must agree to use contraception/barrier as detailed below:
\---- A male condom and an additional highly effective contraceptive method as described in the protocol.
\-- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
* Is a woman of nonchildbearing potential (WONCBP) as defined by the protocol OR
* Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective (with a failure rate of \<1% per year), as described in Appendix 10.4 Contraception and barrier guidance during the study intervention period (to be effective before starting the intervention) and for at least 55 weeks after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.
* Body weight at Screening of 35 kg to 154 kg (77 to 340 lbs), inclusive
Exclusion Criteria
* Sensory CIDP, Distal CIDP and focal CIDP variants.
* Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments
* Poorly controlled diabetes (HbA1c \>7%)
* Serious infections requiring hospitalization within 30 days prior to Screening and any active infection requiring treatment during screening or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections)
* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti-double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.
* Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact benefitrisk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per Investigator's judgment.
* Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on CSSRS during screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.
* Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse
* Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk
* Participant has received immunoglobulins (IVIg or SCIg) within 8 weeks prior to Screening
* Treatment with plasma exchange within the 8 weeks prior to Screening
* Prior treatment with riliprubart
* Prior treatment with (any time) with highly immunosuppressive/chemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine
* Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation
* Prior treatment with B-cell-depleting agents such as rituximab within 6 months prior to riliprubart dosing, or until return of B-cells counts to normal levels, whichever is longer
* Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the halflife of the product, whichever is longer, prior to Screening
* Treatment within 6 months prior to dosing with immunosuppressive/ chemotherapeutic medications, such as cyclophosphamide, methotrexate, tacrolimus, interferon, or tumor necrosis factor (TNF)α inhibitors. Certain immunosuppressants commonly used in CIDP (azathioprine, cyclosporine, or mycophenolate mofetil) are allowed, as indicated under inclusion criterion.
* Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening)
* Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the halflife of the product, whichever is longer, prior to Screening
* Any screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial.
* Positive result of any of the following tests:
* hepatitis B surface antigen (HBsAg)
* antihepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \[antiHBs Ab\] are also positive, indicating natural immunity)
* antihepatitis C virus (antiHCV) antibodies
* antihuman immunodeficiency virus 1 and 2 (antiHIV1 and antiHIV2) antibodies
* Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation
* Accommodation in an institution because of regulatory or legal order; eg, imprisoned or legally institutionalized
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or potential risk for noncompliance to study procedures
* Participants are employees at the clinical study site or other individuals directly involved in the conduct of the study, or immediate family member of such individuals
* Any country related specific regulation that would prevent the participant from entering the study
* Treatment with efgartigimod within 8 weeks prior to screening
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Alabama Neurology Associates- Site Number : 8400019
Homewood, Alabama, United States
USC Norris Comprehensive Cancer Center- Site Number : 8400002
Los Angeles, California, United States
University of California Irvine - Manchester Pavilion- Site Number : 8400007
Orange, California, United States
Yale University School of Medicine- Site Number : 8400018
New Haven, Connecticut, United States
NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
Glenview, Illinois, United States
University of Kansas Medical Center- Site Number : 8400010
Kansas City, Kansas, United States
NeuroMedical Clinic of Central Louisiana- Site Number : 8400031
Alexandria, Louisiana, United States
Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
New Orleans, Louisiana, United States
Johns Hopkins Hospital- Site Number : 8400015
Baltimore, Maryland, United States
Massachusetts General Hospital- Site Number : 8400009
Boston, Massachusetts, United States
Henry Ford Hospital- Site Number : 8400025
Detroit, Michigan, United States
Michigan State University- Site Number : 8400038
East Lansing, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037
St Louis, Missouri, United States
Hospital for Special Surgery- Site Number : 8400041
New York, New York, United States
Columbia University Irving Medical Center- Site Number : 8400003
New York, New York, United States
University of Cincinnati Medical Center- Site Number : 8400020
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center- Site Number : 8400033
Cleveland, Ohio, United States
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
Philadelphia, Pennsylvania, United States
Austin Neuromuscular Center- Site Number : 8400040
Austin, Texas, United States
University of Vermont Medical Center- Site Number : 8400012
Burlington, Vermont, United States
University of Virginia- Site Number : 8400023
Charlottesville, Virginia, United States
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320003
Buenos Aires, , Argentina
Investigational Site Number : 0560001
Leuven, , Belgium
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760012
Vitória, Espírito Santo, Brazil
Hospital Sao Rafael- Site Number : 0760011
Salvador, Estado de Bahia, Brazil
Hospital Moinhos de Vento- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760007
Ribeirão Preto, São Paulo, Brazil
PSEG Centro de Pesquisa Clínica- Site Number : 0760009
São Paulo, , Brazil
Investigational Site Number : 1000002
Blagoevgrad, , Bulgaria
Investigational Site Number : 1000001
Pleven, , Bulgaria
Investigational Site Number : 1240001
Québec, Quebec, Canada
Investigational Site Number : 1520003
Lo Barnechea, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560013
Beijing, , China
Investigational Site Number : 1560010
Beijing, , China
Investigational Site Number : 1560005
Beijing, , China
Investigational Site Number : 1560009
Changsha, , China
Investigational Site Number : 1560011
Chengdu, , China
Investigational Site Number : 1560002
Fuzhou, , China
Investigational Site Number : 1560012
Guangzhou, , China
Investigational Site Number : 1560007
Guangzhou, , China
Investigational Site Number : 1560014
Hangzhou, , China
Investigational Site Number : 1560008
Jinan, , China
Investigational Site Number : 1560015
Nanchang, , China
Investigational Site Number : 1560001
Shanghai, , China
Investigational Site Number : 1560003
Wuhan, , China
Investigational Site Number : 1560006
Wuhan, , China
Investigational Site Number : 1560004
Xi'an, , China
Investigational Site Number : 2030004
Brno, , Czechia
Investigational Site Number : 2030003
Hradec Králové, , Czechia
Investigational Site Number : 2030002
Pardubice, , Czechia
Investigational Site Number : 2080002
Aarhus, , Denmark
Investigational Site Number : 2080001
Copenhagen, , Denmark
Investigational Site Number : 2500001
Le Kremlin-Bicêtre, , France
Investigational Site Number : 2500003
Lille, , France
Investigational Site Number : 2500002
Marseille, , France
Investigational Site Number : 2500005
Montpellier, , France
Investigational Site Number : 2500004
Paris, , France
Investigational Site Number : 2760001
Bad Homburg, , Germany
Investigational Site Number : 2760003
Giessen, , Germany
Investigational Site Number : 2760006
Tübingen, , Germany
Investigational Site Number : 3000002
Athens, , Greece
Investigational Site Number : 3000003
Larissa, , Greece
Investigational Site Number : 3000001
Thessaloniki, , Greece
Investigational Site Number : 3800001
Milan, Milano, Italy
Investigational Site Number : 3800009
Rozzano, Milano, Italy
Investigational Site Number : 3800006
Rome, Roma, Italy
Investigational Site Number : 3800002
Rome, Roma, Italy
Investigational Site Number : 3800008
Rome, Roma, Italy
Investigational Site Number : 3800007
Messina, , Italy
Investigational Site Number : 3800003
Palermo, , Italy
Investigational Site Number : 3800005
Pavia, , Italy
Investigational Site Number : 3800004
Pisa, , Italy
Investigational Site Number : 3920006
Sayama, Osaka, Japan
Investigational Site Number : 3920005
Kawagoe, Saitama, Japan
Investigational Site Number : 3920014
Yaizu, Shizuoka, Japan
Investigational Site Number : 3920011
Bunkyo, Tokyo, Japan
Investigational Site Number : 3920008
Kodaira, Tokyo, Japan
Investigational Site Number : 3920001
Chiba, , Japan
Investigational Site Number : 3920003
Fukuoka, , Japan
Investigational Site Number : 3920009
Saga, , Japan
Investigational Site Number : 3920013
Tokyo, , Japan
Investigational Site Number : 4840003
Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840005
Culiacán, Sinaloa, Mexico
Investigational Site Number : 4840002
Veracruz, , Mexico
Investigational Site Number : 5280001
Amsterdam, , Netherlands
Investigational Site Number : 5280002
Rotterdam, , Netherlands
Investigational Site Number : 6160006
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160002
Lublin, Lublin Voivodeship, Poland
Investigational Site Number : 6160003
Rzeszów, Podkarpackie Voivodeship, Poland
Investigational Site Number : 6200005
Coimbra, , Portugal
Investigational Site Number : 6200004
Lisbon, , Portugal
Investigational Site Number : 6200001
Lisbon, , Portugal
Investigational Site Number : 6200003
Matosinhos Municipality, , Portugal
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240008
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240007
Bilbao, Basque Country, Spain
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240006
Majadahonda, Madrid, Spain
Investigational Site Number : 7240003
Pamplona, Navarre, Spain
Investigational Site Number : 7240005
Oviedo, Principality of Asturias, Spain
Investigational Site Number : 7240002
Valencia, , Spain
Investigational Site Number : 7520001
Stockholm, , Sweden
Investigational Site Number : 1580003
Kaohsiung Niao Sung Dist, , Taiwan
Investigational Site Number : 1580001
Taipei, , Taiwan
Investigational Site Number : 1580002
Taipei, , Taiwan
Investigational Site Number : 7920002
Bursa, , Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920004
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920003
Konya, , Turkey (Türkiye)
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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EFC18156 (Vitalize) \& EFC17236 (MOBILIZE) CIDP website-for potential participants
EFC17236 Plain Language Results Summary
Other Identifiers
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U1111-1295-5755
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-506503-26
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC17236
Identifier Type: -
Identifier Source: org_study_id
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